Cognitive and Progressive Muscle Relaxation Intervention on Couple Undergoing IVF-ET

Overview

The in vitro fertilization and embryo transfer(IVF-ET) is a therapy to help the infertile couples. The mental health status of couple under IVF-ET, commonly seen in depression and anxiety, is found to be closely related to the success of IVF-ET. This study aims to develop a intervention program combing cognitive psychotherapy and progressive muscle relaxation to ease the negative emotion and promote the success rate among couples undergoing IVF-ET.

Full Title of Study: “Cognitive and Progressive Muscle Relaxation Intervention on Couple Undergoing In Vitro Fertilization-Embryo Transfer Treatment”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Supportive Care
    • Masking: Single (Participant)
  • Study Primary Completion Date: June 1, 2020

Interventions

  • Behavioral: Cognitive progressive muscular relaxation therapy
    • This therapy combines cognitive psychotherapy and progressive muscular relaxation, intervened 6 times with 1-1.5 hour each time. The whole therapy will last round 20-30 days during IVF-ET.

Arms, Groups and Cohorts

  • Experimental: Women intervention arm
    • Intervention will be applied to the women within the couple.
  • Experimental: Couple intervention arm
    • Intervention will be applied to the couple, both men and women.
  • No Intervention: Control arm
    • The couple will receive the normal nursing care.

Clinical Trial Outcome Measures

Primary Measures

  • Change of depression score
    • Time Frame: The investigators will measure the socre of depression at baseline and immediately after intervention ( the duration of intervention is around 1 month).
    • The Self-reported Depression Scale (SDS)will be used to assess the score of depression.The total score of SDS ranges from 0-80, with 40 as the cutoff. The higher the total score, the more depressive.
  • Change of anxiety score
    • Time Frame: The investigators will measure the socre of anxiety at baseline and immediately after intervention ( the duration of intervention is around 1 month).
    • The Self-reported Anxiety Scale (SAS) will be used to assess the score of anxiety.The total score of SAS ranges from 0-80, with 30 as the cutoff. The higher the total score, the more anxious.
  • Successful conception rate (%)
    • Time Frame: The doctor will test whether it is successfully conceived 14 days after the embryo is implanted. The last intervention is on the day of embryo implantation. The investigators will count this 14 days after completion of intervention.
    • The investigators will count the successful conception rate at each arms.

Secondary Measures

  • Change of Blood Cortisol
    • Time Frame: The investigators will measure the socre of Blood Cortisol at baseline and immediately after intervention ( the duration of intervention is around 1 month).
    • This is a kind of hormone closely related to stress, and the investigators will measure the level of Blood Cortisol by Blood test.
  • Change of sleeping quality
    • Time Frame: The investigators will measure the socre of sleeping quality at baseline and immediately after intervention ( the duration of intervention is around 1 month).
    • The physical condition closely related to stress. The investigators will use Self-Rating Scale of Sleep to measure the sleeping quality of the participants. The total sore ranges from 5 to 50, with higher score reflects better sleep quality.

Participating in This Clinical Trial

Inclusion Criteria

  • The couple who are eligible for in vitro fertilization-embryo transfer (IVF-ET) treatment;
  • Junior high school and above;
  • voluntarily accepted for investigation and signed informed consent.

Exclusion Criteria

  • Suffering from physical diseases such as severe heart, liver and kidney, and mental disorders;
  • Experiencing major traumatic events in the past 2 years.

Gender Eligibility: All

Biological sex

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Central South University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Anni Wang, Principal Investigator – Central South University
  • Overall Contact(s)
    • Anni Wang, PhD, -86-13467620600, wanganni1990@163.com

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.